MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI BLOOD PARAMETER MONITORING SYSTEM 500; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500

Model Number	500AVHCT
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the user facility's perfusionist, the blood parameter monitor (bpm) seems to come back into calibration but it takes two to three times recalibrating before it does.
Event or Problem Description
It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the initial carbon dioxide (co2) and partial pressure of carbon dioxide (pco2) were off on several cases.The unit was recalibrated.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed the monitor to pass startup self-diagnostics with no failure.The monitor was placed in its service mode and a blood parameter module (bpm) standard reference sensor (srs) test was perform.The monitor's arterial bpm failed several channels which were above service mode limits of 20% to -30% for drift.The monitor was placed in its operate mode with a green srs sensor attached and was operated for over three hours, the ph and carbon dioxide (c02) values of the arterial bpm did not drift.No blood loop testing was done as the inaccuracy was a result of temperature difference.After the temperature transition, the user facility was able to stabilize the shunt.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
Event or Problem Description
Per clinical review: the user facility's perfusionist stated to date that he has had three different occurrences, with the most recent occurrence being (b)(6) 2018 of similar inaccuracies.On (b)(6) 2018, the team calibrated the shunt sensors with gas a and bas b, along with placement of the potassium (k+) code into the monitor prior to every procedure.The team calibrated the values with the first in-vivo.The end-user stated that the variances of all the values (ph, partial pressure of carbon dioxide (pco2), and partial pressure of oxygen (po2)) are out of the accuracy specifications and it is taking two to three times performing in-vivo to bring the values into line with what is expected versus the blood gas analyzer.The perfusionist stated that they know their prime solution has a ph of between 7.0 and 7.8 units, and that the blood during the procedures are within that range.The team has not changed any of their clinical practices recently to have a change in what their expectations of the clinical parameter values should be.They have not changed the temperatures drastically, and always do a in-vivo with all subsequent gases.Secondarily, during these procedures, the perfusionist stated that they cool to between 28 degrees celsius (c) and 32 degrees c.The team did not change out the monitor nor the shunt sensor during the procedure.The team mitigated the questionable values by using the epoch blood gas analyzer.There was no blood loss or harm associated with the occurrences.There was no delay in the surgical procedures due to the concerns about the blood parameter monitor (bpm).

• Brand Name: CDI BLOOD PARAMETER MONITORING SYSTEM 500
• Common Device Name: MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 7819988
• Report Number: 1828100-2018-00442
• Device Sequence Number: 2434337
• Product Code: DRY
• UDI-Device Identifier: 00886799001646
• UDI-Public: (01)00886799001646(11)990708
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 500AVHCT
• Device Catalogue Number: 500AVHCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 09/10/2018; 10/19/2018; 12/12/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 10/05/2018; 11/09/2018; 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1828100-08/07/15-002-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BLOOD GAS ANALYZER